NCT01690182

Brief Summary

The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. In collaboration with food manufacturer Unilever, the investigators want to image the abdomen of healthy volunteers after consumption of test meals of varying volume and energy density to determine levels of gastric distension and investigate possible correlations of this with the subjects' sense of satiety.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable healthy

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

September 17, 2012

Last Update Submit

December 17, 2012

Conditions

Healthy

Keywords

Gastrointestinal physiologyMRIgastric volumessatiety

Outcome Measures

Primary Outcomes (1)

  • Total gastric content half emptying time T50

    Total gastric volume at half the experimental time

    0 - 240 mins

Secondary Outcomes (1)

  • Volumes of test meal in the stomach

    0 - 240 mins

Other Outcomes (1)

  • Relationship of gastric behaviour of test meal stomach volumes with satiety

    0 - 240 minutes

Study Arms (3)

Study test meal 1

EXPERIMENTAL

High volume, high energy density test meal. Volunteers will be given 490 mL of a high energy test meal once in the morning

Dietary Supplement: Study test meal 1

Study test meal 2

EXPERIMENTAL

High volume, low energy density test meal. Volunteers will be given 490 mL of a high volume low energy density test meal once in the morning

Dietary Supplement: Study test meal 2

Study test meal 3

EXPERIMENTAL

A low volume, high energy test meal. Volunteers will be given 140 mL high energy density test meal once in the morning.

Dietary Supplement: Study test meal 3

Interventions

Study test meal 1DIETARY_SUPPLEMENT

Volunteers will be fed with a high volume, high energy density test meal.

Study test meal 1
Study test meal 2DIETARY_SUPPLEMENT

Volunteers will be fed with a high volume, low energy density test meal

Study test meal 2
Study test meal 3DIETARY_SUPPLEMENT

Volunteers will be fed with a low volume, high energy density test meal

Study test meal 3

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy; no medical conditions that might affect the study measurements (as determined by the study physician)
  • No use of medication that would interfere with the study measurements (as determined by the study physician)
  • No use of antibiotics in the 3 months before the study or during the study
  • No reported participation in another nutritional or biomedical trial 3 months before the study or during the study
  • Being used to eating 3 meals daily
  • BMI: 20 - 35 kg m-2
  • No reported participation in night shift work 2 weeks prior to the study or during the study
  • Not taking part in strenuous exercise ≤10 hours/week
  • Not consuming more than 21 alcoholic test meals in a typical week
  • Not presently a smoker
  • No reported weight loss or gain of more than 10 % of bodyweight for 6 months before the study
  • No eating disorder
  • No MRI contraindications; i.e absence of metal implants, infusion pumps and pacemakers, as assessed by a MRI safety screening questionnaire

You may not qualify if:

  • High or very high restrained eater
  • Use of any medically- or self-prescribed diet for the duration of the study
  • Allergies or food intolerances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unilever Research and Development

Olivier Van Noortlann 120, AT Vlaardingen, 3133, Netherlands

Location

Nottingham Digestive Diseases Centre and Sir Peter Mansfield Magnetic Resonance Centre

University of Nottingham, Nottingham, NG7 2RD, United Kingdom

Location

Related Publications (1)

  • Murray K, Placidi E, Schuring EA, Hoad CL, Koppenol W, Arnaudov LN, Blom WA, Pritchard SE, Stoyanov SD, Gowland PA, Spiller RC, Peters HP, Marciani L. Aerated drinks increase gastric volume and reduce appetite as assessed by MRI: a randomized, balanced, crossover trial. Am J Clin Nutr. 2015 Feb;101(2):270-8. doi: 10.3945/ajcn.114.096974. Epub 2014 Dec 3.

    PMID: 25646323DERIVED

Study Officials

  • Luca Marciani, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 21, 2012

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

GB(1)NL(1)